UMIN-CTR Clinical Trial

Basic information
Public title	Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Acronym	Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Scientific Title	Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Scientific Title:Acronym	Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the capability of time-resolved spectroscopy (TRS) on evaluation of deep brain regions by comparing TRS-derived hemodynamic data with cerebral blood and volume data measured by positron emission tomography (PET).
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemoglobin concentration and tissue oxygen saturation measured by time-resolved spectroscopy. Cerebral blood volume and cerebral blood flow by PET.
Key secondary outcomes	Relationship between the levels of hemoglobin concentration at the forehead and the deep brain tissue.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Measurements of hemodynamic data from the time resolved spectroscopy system and cerebral blood flow/ volume from the PET system during motor, cognitive and sensory tasks. MRI measurement during the resting state.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1.A healthy adult (20 years old and over, 59 years old or younger). 2.Individuals who are consent to participate in this study.
Key exclusion criteria	1.Individuals who are judged inadequacy for participation of this study by doctor or research director. 2.Individuals who have one or multiple following diagnosis: dementia, mild degree of dementia, brain damage, Parkinson disease, psychiatric disease and claustrophobia. 3.Individuals who have one or multiple following symptoms or disease: hearing difficulty, impaired vision and finger tremor. 4.Individuals whose heads with TRS probes on cannot be placed safely into the gantry of the PET camera. 5.Individuals who are judged inadequacy for participation of MRI examination by doctor or operator from the MRI checklist results. 6.Individuals who are pregnant or having a possibility of pregnancy.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Yukio Middle name Last name Ueda
Organization	Hamamatsu Photonics K.K.
Division name	The 7th Research Group, Central Research Laboratory
Zip code	4348601
Address	5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL	053-586-7111
Email	ueda@crl.hpk.co.jp

Public contact
1st name of contact person	1st name Hiroaki Middle name Last name Suzuki
Organization	Hamamatsu Photonics K.K.
Division name	The 7th Research Group, Central Research Laboratory
Zip code	4348601
Address	5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL	053-586-7111
Homepage URL
Email	hiro-su@crl.hpk.co.jp

Sponsor
Institute	Hamamatsu Photonics K.K.
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hamamatsu Medical Photonics Foundation.
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Hamamatsu Medical Photonics Foundation.
Address	5000, Hirakuchi Hamakita-ku, Hamamatsu City, Shizuoka, Japan
Tel	053-584-6581
Email	takagi@hmp.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	8
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 30 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 05 Month 14 Day
Last follow-up date	2019 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 14 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037160